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Behavioral Intervention
Early Physical Therapy for Lockjaw (PRECISE Trial)
N/A
Waitlist Available
Led By Margaret McNeely, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of oral, oropharyngeal, or nasopharyngeal cancer
Be older than 18 years old
Must not have
Previous surgery for the temporomandibular joint not related to the HNC diagnosis
Local cancer recurrence or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study ways to help individuals with head and neck cancer who experience restricted jaw movement. They will conduct a small study with 30 participants undergoing radiation therapy, comparing usual care with a new
Who is the study for?
This trial is for individuals with head and neck cancer who are about to undergo radiation therapy. They should be new patients at the HNC clinic and willing to participate in a study that could involve additional physical therapy.
What is being tested?
The trial is testing whether early physical therapy can help prevent or reduce trismus (lockjaw) compared to usual care, which involves exercises and referral for physical therapy only after trismus is detected.
What are the potential side effects?
Since this intervention includes supportive care like manual therapy and jaw exercises, side effects may include discomfort or pain from the exercises, fatigue of the jaw muscles, or soreness from manual therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cancer in my mouth, throat, or the upper part of my throat behind the nose.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had surgery on my jaw joint not related to head or neck cancer.
Select...
My cancer has returned or spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility: completion rate
Secondary study objectives
Cervical range of motion
Feasibility: adherence rate
Feasibility: recruitment rate
+5 moreSide effects data
From 2023 Phase 1 & 2 trial • 28 Patients • NCT04345601100%
Anemia
70%
Blood bicarbonate decreased
70%
Hypophosphatemia
60%
Alanine aminotransferase increased
60%
Aspartate aminotransferase increased
60%
Fever
50%
Hypokalemia
50%
Platelet count decreased
50%
Blood bilirubin increased
50%
Hypocalcemia
50%
Hyperphosphatemia
40%
Hypernatremia
40%
Creatinine increased
30%
Respiratory, thoracic and mediastinal disorders - Other, specify:Hypercapnia
30%
Hyponatremia
30%
Hypercalcemia
30%
Hypoalbuminemia
30%
White blood cell decreased
20%
Hypoxia
20%
Constipation
20%
Lymphocyte count decreased
20%
Anxiety
20%
Hyperkalemia
20%
Headache
10%
Delirium
10%
Cardiac arrest
10%
Anorexia
10%
Rash maculo-papular
10%
Fall
10%
Diarrhea
10%
Depression
10%
Abdominal pain
10%
CPK increased
10%
Cardiac troponin I increased
10%
Hypermagnesemia
10%
Nausea
10%
Seizure
10%
INR increased
10%
Eosinophilia
10%
Febrile neutropenia
10%
Hypertension
10%
Hypotension
10%
Lung infection
10%
Urinary tract infection
10%
Ileus
10%
Sepsis
10%
Confusion
10%
Activated partial thromboplastin time prolonged
10%
Fatigue
10%
Epistaxis
10%
Multi-organ failure
10%
Rectal hemorrhage
10%
Neutrophil count decreased
10%
Skin and subcutaneous tissue disorders - Other, specify:rash - unspecified
10%
Pneumothorax
10%
Acute kidney injury
10%
Peripheral sensory neuropathy
10%
Hypothermia
10%
Fungemia
10%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesenchymal Stromal Cells (MSCs)
Control Group
Safety Run In
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective Surveillance for Trismus and Early Physical Therapy InterventionExperimental Treatment1 Intervention
Weekly monitoring of mouth opening and jaw function. Early intervention if the participant presents with 5% or greater reduction in mouth opening compared to pre-treatment measures. Early intervention will comprise: physical therapy, home exercises and use of a jaw stretching device.
Group II: Usual CareActive Control1 Intervention
Home exercise instruction and referral to physical therapy if trismus develops.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supportive Care
2013
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
936 Previous Clinical Trials
433,797 Total Patients Enrolled
1 Trials studying Trismus
10 Patients Enrolled for Trismus
Alberta Health servicesOTHER
162 Previous Clinical Trials
651,554 Total Patients Enrolled
Margaret McNeely, PhDPrincipal InvestigatorUniversity of Alberta
6 Previous Clinical Trials
256 Total Patients Enrolled
1 Trials studying Trismus
10 Patients Enrolled for Trismus
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